West Nile Virus inactivation by the solvent/detergent steps of the second and third generation manufacturing processes for B-domain deleted recombinant factor VIII.

West Nile Virus (WNV) was immediately and completely inactivated to below assay detection limits upon addition of solvent/detergent (S/D) to intermediate process pools of second and third generation B-domain deleted recombinant Factor VIII (BDDrFVIII; ReFacto, Wyeth, Cambridge, MA, USA). We verify that the S/D step provides robust enveloped virus inactivation (>5 log(10)) and functions as a WNV barrier.